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WO2024135691A1 - Dispositif de détachement de spirale d'embolisation - Google Patents

Dispositif de détachement de spirale d'embolisation Download PDF

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Publication number
WO2024135691A1
WO2024135691A1 PCT/JP2023/045530 JP2023045530W WO2024135691A1 WO 2024135691 A1 WO2024135691 A1 WO 2024135691A1 JP 2023045530 W JP2023045530 W JP 2023045530W WO 2024135691 A1 WO2024135691 A1 WO 2024135691A1
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WIPO (PCT)
Prior art keywords
coil
pusher
engagement
embolic coil
wire
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PCT/JP2023/045530
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English (en)
Japanese (ja)
Inventor
修二 磯崎
京典 白川
Original Assignee
株式会社パイオラックスメディカルデバイス
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Application filed by 株式会社パイオラックスメディカルデバイス filed Critical 株式会社パイオラックスメディカルデバイス
Publication of WO2024135691A1 publication Critical patent/WO2024135691A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord

Definitions

  • the present invention relates to an embolic coil detachment device for detaching embolic coils used, for example, in the treatment of aneurysms, at a desired position within the body.
  • an embolization coil when treating an aneurysm, multiple embolization coils are filled into the aneurysm to block the blood flow and prevent rupture, or when administering an anti-cancer drug, an embolization coil is placed in a specific blood vessel among multiple branched blood vessels to block the blood flow and allow the anti-cancer drug to flow more easily in other blood vessels, thereby treating the affected area.
  • Patent Document 1 describes a composite pusher assembly-coil assembly that includes a coil assembly having opposing ends on the coil axis and a coil equipped with a connecting fastener at at least one end that can be connected to another connecting fastener that is a connecting partner, and a pusher assembly having a tubular pusher jacket that is adapted to fit within a catheter jacket and another connecting fastener disposed at the distal end of the tubular pusher jacket, in which the connecting fastener of the coil assembly is connected to the connecting fastener of the pusher assembly.
  • Each connecting fastener is generally cylindrical in shape, with a concave central area formed in its axial center by cutting or other processing, and its tip or base end is attached to the base end of the coil or the tip of the pusher.
  • the end of one connecting fastener engages with the concave central area of the other connecting fastener, thereby fixing the two connecting fasteners to each other and connecting the coil assembly and the pusher assembly (see lines 24-33 in the right column on page 5 of the specification of Patent Document 1, and Figures 1A and 1B of Patent Document 1).
  • the connecting fastener on the coil assembly side is separate from the coil and is formed by cutting or other processes, so it is hard and has high rigidity. This makes it difficult to insert into human tissue such as curved tubular organs or curved body cavities.
  • the object of the present invention is therefore to provide an embolic coil detachment device that is easy to insert into curved tubular organs, human tissue, etc.
  • the present invention provides an embolic coil removal device having an embolic coil formed by winding coil wire and a pusher disposed on the base end side of the embolic coil for pushing the embolic coil, characterized in that the base end of the embolic coil is provided with a first engagement portion that engages with the tip of the pusher, the first engagement portion having a coil gap portion formed by leaving a gap between the coil wires in the axial direction, and the tip of the pusher is provided with a second engagement portion that can engage with the coil gap portion from the radial direction of the embolic coil.
  • the coil gap portion of the first engagement portion provided at the base end of the embolization coil is formed with a gap in the axial direction between the coil wires, so that it is highly flexible and the flexibility of the engagement portion between the first engagement portion and the second engagement portion can be improved, making it easier to insert into curved tubular organs, body cavities, etc.
  • FIG. 1 is an explanatory diagram showing a first embodiment of an embolic coil detachment device according to the present invention.
  • FIG. FIG. 2 is an enlarged cross-sectional view of a main portion of the embolic coil detachment device.
  • 13 is an explanatory diagram of the embolic coil detachment device in a state in which an engagement portion is protruding from a distal end of a catheter.
  • FIG. 13 is an enlarged cross-sectional view of a main portion of the embolic coil detachment device in a state in which the movable wire has been removed from within the embolic coil.
  • FIG. 13 is an explanatory diagram of the embolic coil detachment device in a state where the embolic coil has been detached from the pusher.
  • FIG. 13 is an explanatory diagram showing the state in which an embolic coil is placed in an affected area using the embolic coil detachment device.
  • FIG. FIG. 2 shows an enlarged explanatory view of a main portion of an embolic coil detachment device according to a second embodiment of the present invention.
  • FIG. 13 is an enlarged explanatory view of a main portion of an embolic coil detachment device according to a third embodiment of the present invention.
  • 13 is an enlarged explanatory view of a main portion of the embolic coil detachment device when the movable wire is pulled out from within the embolic coil with the engaging portion housed within the catheter.
  • FIG. 13 is an enlarged explanatory view of a main portion of an embolic coil detachment device according to a fourth embodiment of the present invention. 13 is an explanatory diagram showing how the embolic coil constituting the embolic coil detachment device is housed in a medical tube.
  • FIG. FIG. 2 is an explanatory diagram of the state in which the embolic coil constituting the embolic coil detachment device is housed in a medical tube.
  • This embolic coil detachment device has an embolic coil made of wound coil wire, and a pusher that is disposed on the base end side of the embolic coil and pushes the embolic coil. More specifically, as shown in Figures 1, 2, and 5, this embodiment of the embolic coil detachment device 10 (hereinafter also simply referred to as the "coil detachment device 10") has an embolic coil 20 made of wound coil wire 21, a pusher 40 that has an inner cavity 43 and is disposed on the base end side 25 of the embolic coil 20 and pushes the embolic coil 20, and a movable wire 60 that is removably inserted into the embolic coil 20 and the inner cavity 43 of the pusher 40.
  • the coil detachment device 10 is inserted into a medical tube 70 such as a catheter and moves within the medical tube 70.
  • the "base end” or “base end” of each component refers to the end or end (proximal end, proximal end) that is closest to the hand of the user using the coil detachment device 10
  • the "tip end” or “tip” refers to the end or end (distal end, distal end) opposite the base end or base end.
  • the embolization coil 20 is formed by winding coil wire 21, and has an internal space 23 inside through which the movable wire 60 can be inserted.
  • the embolization coil 20 has a densely wound portion where the coil wires 21, 21 are closely spaced in the axial direction, and/or a loosely wound portion where the coil wires 21, 21 are spaced apart in the axial direction, and the base end 25 of the embolization coil 20 has a first engagement portion 29 that engages with the tip 45 of the pusher 40, and the first engagement portion 29 has a coil gap portion 31 where the coil wires 21, 21 are spaced apart in the axial direction, or where the coil gap portion 31 is wider than the axial gap between the coil wires 21, 21 in the loosely wound portion.
  • the embolization coil 20 has a densely wound portion 27 on the distal side of the base end 25, formed by winding the coil wires 21, 21 closely together in the axial direction (the coil wires 21, 21 are wound around each other without leaving any gaps in the axial direction).
  • the embolization coil 20 has a densely wound portion 27 in the range from the axial tip (not shown) to the axial tip beyond the base end 25.
  • the inclination angle ⁇ 1 of the coil wire 21 with respect to the axis C1 of the embolization coil 20 in the densely wound portion 27 is the same for all of them.
  • the base end 25 of the embolization coil 20 is provided with a first engagement portion 29 that engages with the tip end 45 of the pusher 40.
  • the first engagement portion 29 also has a coil gap portion 31 that is formed by leaving a gap between the coil wires 21, 21 in the axial direction.
  • the oblique extension portion 22 extends diagonally from the base end 27a of the densely wound portion 27 toward the base end 25 at a predetermined length with an inclination angle different from the inclination angle ⁇ 1 of the coil wire 21 in the densely wound portion 27.
  • the inclination angle of the oblique extension portion 22 with respect to the axis C1 of the embolization coil 20 is referred to as the "inclination angle ⁇ 2.”
  • the diagonal extension portion 22 is then densely wound several times (four times in this example) from the tip of the extension direction toward the base end of the embolization coil 20 to provide an engagement end 33.
  • the inclination angle of the coil wire 21 at the engagement end 33 relative to the axis C1 of the embolization coil 20 is the same as that of the densely wound portion 27 (inclination angle ⁇ 1).
  • a coil gap portion 31 is provided between the coil wire 21 located at the base end 27a of the densely wound portion 27 and the coil wire 21 located at the tip side of the embolization coil 20 among the coil wire 21 forming the engagement end 33.
  • the coil gap portion 31 is formed between the densely wound portion 27 and the engagement end 33 of the embolization coil 20 via the diagonal extension portion 22.
  • each part of the embolization coil 20 in this embodiment is formed integrally and continuously from a single coil wire 21 (integrally formed without being divided or cut along the way).
  • the embolization coil 20 is formed from its axial tip to its axial base end (all parts including the densely wound portion 27, the diagonal extension portion 22, the coil gap portion 31, the engagement end 33, the base end 25, etc.) from a single coil wire 21.
  • the coil gap portion 31 and the engagement end portion 33 described above form the "first engagement portion 29.”
  • the embolization coil 20 is also fitted with an extension restriction wire 35 that restricts extension.
  • the extension restriction wire 35 is fitted in the range from the base end 27a of the densely wound portion 27 of the embolization coil 20 to a midpoint in the axial direction.
  • the extension restriction wire 35 extends to an extent that does not inhibit the bending deformation of the embolization coil 20 (see FIG. 6), but restricts the formation of gaps between adjacent coil wires 21, 21 of the embolization coil 20 (in the present embodiment), or, even if a gap is set between the coil wires 21, 21, restricts the gap from expanding beyond a predetermined value.
  • the extension restriction wire 35 may also be attached to the area extending from the base end to the tip end of the embolic coil 20 (this will be described in the fourth embodiment below).
  • polyurethane, polypropylene, nylon elastomer, polyethylene, polytetrafluoroethylene (PTFE), etc. can be used as the extension restriction wire 35.
  • the coil wire 21 forming the embolization coil 20 is a round wire with a circular cross section.
  • the embolization coil 20 shown in Figures 1 to 5 extends straight, but this is for the sake of convenience in order to make the explanation easier to understand.
  • the embolization coil 20 is shaped to a specified shape, such as the vascular occlusion device described in Japanese Patent Application No. 2004-135307 (Japanese Patent Publication No. 2005-312724) filed by the present applicant.
  • the pusher 40 in this embodiment is in the form of a coil made by winding pusher wire 41, and has an inner cavity 43 inside which the movable wire 60 can be inserted.
  • the tip 45 of the pusher 40 is provided with a second engagement portion 49 that can engage with the coil gap portion 31 from the radial direction of the embolization coil 20.
  • the pusher 40 and the embolization coil 20 are also configured as follows:
  • the pusher 40 has a densely wound portion where the pusher wires 41, 41 are closely spaced in the axial direction on the proximal side of the tip 45, and/or a loosely wound portion where the pusher wires 41, 41 are spaced apart in the axial direction.
  • the second engagement portion 49 has a pusher gap portion 51 where the pusher wires 41, 41 are spaced apart in the axial direction, or where the gap between the pusher wires 41, 41 in the loosely wound portion is wider than the gap between the pusher wires 41, 41 in the axial direction.
  • the pusher wire 41 can be inserted into the coil gap portion 31 from the radial direction of the embolization coil 20, and the coil wire 21 can be inserted into the pusher gap portion 51 from the radial direction of the pusher 40.
  • the pusher 40 has a densely wound portion 47 nearer the base end than the tip end 45, in which the pusher wires 41, 41 are wound closely together in the axial direction (the pusher wires 41, 41 are wound around each other without leaving any gaps in the axial direction).
  • the densely wound portion 47 is composed of a first densely wound portion 47a arranged in a predetermined range from the axial base end (not shown) toward the axial tip, an X-ray visible portion 47b made of an X-ray opaque material connected to the tip of the first densely wound portion 47a, and a second densely wound portion 27c connected to the tip of the X-ray visible portion 47b.
  • the tip of the first densely wound portion 47a and the base end of the X-ray visible portion 47b, and the tip of the X-ray visible portion 47b and the base end of the second densely wound portion 47c are fixed to each other by welding, adhesive, etc.
  • the inclination angle ⁇ 3 of the pusher wire 41 with respect to the axis C2 of the pusher 40, which constitutes each of the parts 47a, 47b, and 47c of the densely wound portion 47, is the same for all of them.
  • the tip 45 of the pusher 40 is provided with a second engagement portion 49 that can engage with the coil gap portion 31 from the radial direction of the embolization coil 20.
  • the second engagement portion 49 also has a pusher gap portion 51 that is formed between the pusher wires 41, 41 with a gap in the axial direction.
  • the second engagement portion 49 can be disengaged from the coil gap portion 31 in the radial direction of the embolization coil 20.
  • the oblique extension portion 42 extends diagonally from the tip 47d of the second densely wound portion 47c toward the tip of the pusher 40 at a predetermined length with an inclination angle different from the inclination angle ⁇ 3 of the pusher wire 41 in the densely wound portion 47.
  • the inclination angle of the oblique extension portion 42 with respect to the axis C2 of the pusher 40 is referred to as "inclination angle ⁇ 4.”
  • the wire is densely wound several times (four times in this case) toward the tip of the pusher 40 to provide an engagement end portion 53.
  • the inclination angle of the pusher wire 41 at the engagement end portion 53 with respect to the axis C2 of the pusher 40 is the same as that of the densely wound portion 47 (inclination angle ⁇ 3).
  • a pusher gap portion 51 is provided between the pusher wire 41 located at the tip 47d of the second densely wound portion 47c and the coil wire 21 that is located on the base end side of the pusher 40 among the coil wires 21 that form the engagement end 53.
  • the pusher gap portion 51 is formed between the second densely wound portion 47c and the engagement end 53 of the pusher 40 via the diagonal extension portion 42.
  • At least the second densely wound portion 47c and the tip portion 45 are integrally and continuously formed by a single pusher wire 41.
  • the pusher gap portion 51 and the engagement end portion 53 form the "second engagement portion 49.”
  • Figure 5 shows the state in which the second engagement portion 49 of the pusher 40 and the first engagement portion 29 of the embolic coil 20 have been disengaged from each other, and the embolic coil 20 has been detached from the pusher 40.
  • the distal end 45 of the pusher 40 and the proximal end 25 of the embolic coil 20 are radially misaligned, and the embolic coil 20 and the pusher 40 are no longer coaxially arranged.
  • the engagement end 53 of the pusher 40 is inserted radially into the coil gap portion 31 of the embolic coil 20. Then, the engagement end 53 of the pusher 40 enters the coil gap portion 31, and the engagement end 33 of the embolic coil 20 is inserted radially into the pusher gap portion 51 of the pusher 40, so that the engagement end 33 of the embolic coil 20 enters the pusher gap portion 51.
  • the diagonal extension portion 42 on the pusher 40 side engages to surround the outer periphery of the engagement end 33 of the embolization coil 20 (engages while abutting against the outer periphery of the axially adjacent coil wire 21 that constitutes the engagement end 33), and the diagonal extension portion 22 on the embolization coil 20 side engages to surround the outer periphery of the engagement end 53 of the pusher 40 (engages while abutting against the outer periphery of the axially adjacent pusher wire 41 that constitutes the engagement end 53), and both engagement portions 29, 49 engage with each other.
  • the engagement end 33, 53 of one of the members of the embolic coil 20 or the pusher 40 enters the gap portion 31, 51 of the other member of the embolic coil 20 or the pusher 40, and the first engagement portion 29 and the second engagement portion 49 engage with each other, correcting the radial positional deviation between the tip end 45 of the pusher 40 and the base end 25 of the embolic coil 20, and the embolic coil 20 and the pusher 40 are arranged coaxially.
  • the engagement portion where the first engagement portion 29 and the second engagement portion 49 are engaged has an enlarged diameter portion that is larger in diameter than the other portions.
  • the diagonal extension portion 42 on the pusher 40 side engages to surround the outer periphery of the engagement end 33 of the embolization coil 20, so that the tip portion 42a in the extension direction of the diagonal extension portion 42 protrudes slightly radially outward from the outer periphery of the pusher 40 (expanded in diameter) as shown in FIG. 2.
  • the diagonal extension portion 22 on the embolization coil 20 side engages to surround the outer periphery of the engagement end 53 of the pusher 40, so that the tip portion 22a in the extension direction of the diagonal extension portion 22 protrudes slightly radially outward beyond the outer periphery of the embolization coil 20 (expanded in diameter), as shown in FIG. 2.
  • the pusher 40 and the embolization coil 20 have approximately the same outer diameter, except for the tip portions 42a, 22a.
  • the tip portion 42a of the diagonal extension portion 42 of the pusher 40 and the tip portion 22a of the diagonal extension portion 22 of the embolization coil 20 form the "expanded diameter portion" described above.
  • the pusher wire 41 forming the pusher 40 is a round wire having a circular cross section.
  • the pusher wire 41 forming the X-ray visible portion 47b is made of an X-ray opaque metal such as W, Pt, Ti, Pd, Rh, Au, Ag, Bi, Ta, or an alloy thereof. It is preferable that the degree of X-ray opacity of the coil wire 21 is greater than the degree of X-ray opacity of the pusher wire 41. In this case, under X-ray fluoroscopy, the X-ray fluoroscopic image of the embolization coil 20 appears whiter and more clearly visible than the X-ray fluoroscopic image of the pusher 40, making it easier to grasp the position of the embolization coil 20 within the body.
  • the pusher wire 41 has lower rigidity than the coil wire 21.
  • the movable wire 60 When the movable wire 60 is inserted into the embolic coil 20 and into the lumen 43 of the pusher 40, it maintains an engaged state between the first engaging portion 29 and the second engaging portion 49, and when it is pulled out from inside the embolic coil 20, it is possible to release the engagement between the first engaging portion 29 and the second engaging portion 49.
  • the movable wire 60 in this embodiment is a solid, linear member that extends in a straight line. As shown in FIG. 2, when the movable wire 60 is inserted into the internal space 23 of the embolic coil 20 and the lumen 43 of the pusher, even if the engagement end 33, 53 of one member (either the embolic coil 20 or the pusher 40) attempts to disengage radially outward from the gap portion 31, 51 of the other member (either the embolic coil 20 or the pusher 40), the movable wire 60 restricts radial movement and prevents disengagement, thereby maintaining the engagement between the first engagement portion 29 and the second engagement portion 49.
  • the coil removal device 10 is also movable within the medical tube 70.
  • This medical tube 70 is cylindrical and extends to a predetermined length.
  • X-ray visible markers 73, 73 made of X-ray opaque metals such as W, Pt, Ti, Pd, Rh, Au, Ag, Bi, Ta, and alloys thereof are embedded in the tip 71 of the medical tube 70 in the extension direction and in the middle of the extension direction.
  • the inner diameter of the medical tube 70 is larger than the outer diameter of the embolic coil 20 and the outer diameter of the pusher 40.
  • the outer diameter of the embolic coil 20 and the outer diameter of the pusher 40 are smaller than the inner diameter of the medical tube 70. Therefore, the embolic coil 20 and the pusher 40 can slide within the medical tube 70.
  • the embolization coil 20 is configured to have a densely wound portion 27, but the embolization coil may also have a loosely wound portion in which the coil wire is spaced apart in the axial direction, or may be a combination of a densely wound portion and a loosely wound portion. If the embolization coil has a loosely wound portion, the coil gap portion of the first engagement portion will be wider than the gap between the coil wire in the loosely wound portion.
  • the pusher 40 in this embodiment is configured to have a densely wound portion 47
  • the pusher may have a loosely wound portion in which the pusher wire is spaced apart in the axial direction, or may be a combination of a densely wound portion and a loosely wound portion. If the pusher has a loosely wound portion, the coil gap portion of the second engagement portion will be wider than the gap between the pusher wire in the loosely wound portion.
  • the pusher need not only be coil-shaped, but may also be, for example, tubular with an inner lumen (internal space) made of metal material, synthetic resin material, etc., or solid with no inner lumen made of metal material, synthetic resin material, etc., and there are no particular limitations on its shape or structure as long as it is capable of pushing the embolization coil.
  • the engagement end 33 of the embolization coil 20 and the engagement end 53 of the pusher 40 are both tightly wound with four turns of wire 21, 41, but the number of turns at the engagement end may be 1, 2, 3, or 5 or more.
  • the engagement end 33 of the embolic coil 20 and the engagement end 53 of the pusher 40 are integrally formed and continuous with the embolic coil 20 and the pusher 40, but the engagement end may be separate from the embolic coil and the pusher and attached to the embolic coil and the pusher by welding, adhesive, etc.
  • the engagement end 33 of the embolic coil 20 and the engagement end 53 of the pusher 40 are arranged to be positioned coaxially with the densely wound portions 27, 47, but the engagement end may be shaped to have a predetermined shape relative to the densely wound portions of the embolic coil and the pusher (this will be explained in the embodiment shown in Figure 7).
  • the coil wire 21 and the pusher wire 41 are both round wires with a circular cross section, but the coil wire and the pusher wire may also be wires with, for example, a square or elliptical cross section.
  • the wire diameter of the wires 21, 41 is constant, but for example, the thickness may be changed in parts (this will be explained in the embodiment shown in Figure 7).
  • the engaging ends 33, 53 are formed as a single unitary part made by tightly winding a plurality of wires 21, 41, and the single engaging end 33, 53 engages with the opposing diagonal extending portion 22, 42, so that the two engaging portions 29, 49 engage with each other (see FIG. 2).
  • the outer diameter of the densely wound portion 27 of the embolic coil 20 and the outer diameter of the engagement end 33 of the first engagement portion 29 are configured to be the same, and the outer diameter of the densely wound portion 47 of the pusher 40 and the outer diameter of the engagement end 53 of the second engagement portion 49 are also configured to be the same.
  • the outer diameter of the engagement end of the first engagement portion may be formed to be smaller or larger than the outer diameter of the densely wound portion, or in the pusher, the outer diameter of the engagement end of the second engagement portion may be formed to be smaller or larger than the outer diameter of the densely wound portion.
  • the pusher wire 41 has a lower rigidity than the coil wire 21, but the pusher wire may have the same rigidity as the coil wire or may have a higher rigidity than the coil wire.
  • the coil detachment device 10 in this embodiment is configured to have an embolic coil 20, a pusher 40, and a movable wire 60, but the embolic coil detachment device may also be configured not to have a movable wire (this will be explained in the fourth embodiment below).
  • the engaging end 33, 53 of one of the members of the embolic coil 20 or the pusher 40 is inserted into the gap portion 31, 51 of the other member of the embolic coil 20 or the pusher 40, and the first engaging portion 29 and the second engaging portion 49 are engaged with each other.
  • the movable wire 60 is inserted into the internal space 23 of the embolic coil 20 and the inner cavity 43 of the pusher 40.
  • the engaged state between the first engaging portion 29 and the second engaging portion 49 is maintained, and the embolic coil 20 is held at the tip side of the pusher 40.
  • a contrast agent is administered into the body, and then under X-ray fluoroscopy (radioactive fluoroscopy), the medical tube 70 is guided and moved via a guide wire (not shown) using the well-known Seldinger technique or the like until its tip reaches a predetermined position.
  • the tip 71 of the medical tube 70 is inserted into the affected area A, such as an aneurysm.
  • the guide wire is pulled out from the body.
  • the coil detachment device 10 is inserted from the tip side (embolization coil 20 side) into the base end side of the medical tube 70. Then, while pushing the embolization coil 20 with the pusher 40, the embolization coil 20 is moved within the medical tube 70. Thereafter, as shown in FIG. 3, the embolization coil 20 is pushed out from the opening of the tip end 71 of the medical tube 70, and the first engagement portion 29 of the embolization coil 20 and the second engagement portion 49 of the pusher 40 are caused to protrude from the opening of the tip end 71 of the medical tube 70.
  • the movable wire 60 is pulled out from the internal space 23 of the embolic coil 20 and pulled so that it is not positioned within the lumen 43 at the tip 45 of the pusher 40.
  • the engagement end 53 of the pusher 40 can be detached radially outward from the coil gap portion 31 of the embolic coil 20, and the engagement end 33 of the embolic coil 20 can be detached radially outward from the pusher gap portion 51 of the pusher 40.
  • the engagement between the engagement parts 29, 49 may be automatically released when the engagement parts 29, 49 are protruded from the tip opening of the medical tube 70 without the twisting or twisting operations described above.
  • the coil gap portion 31 of the first engagement portion 29 provided at the base end portion 25 of the embolization coil 20 is formed with a gap between the coil wires 21, 21 in the axial direction (the gap is widened).
  • the flexibility of the coil gap portion 31 of the embolic coil 20 can be increased to improve the flexibility of the engagement portion between the first engagement portion 29 and the second engagement portion 49. Therefore, from a state in which the movable wire 60 is pulled out from within the embolic coil 20 to release the engagement between the two engagement portions 29, 49, it is possible to release the engagement between the two engagement portions 29, 49 by, for example, pulling the pusher 40 toward the hand side.
  • the coil wire 21 that forms the embolization coil 20 can be used to provide a first engagement portion 29 having a coil gap portion 31, improving the manufacturing workability of the embolization coil 20 and reducing costs.
  • the base end 25 of the embolic coil 20 is provided with only a first engagement portion 29 having a coil gap portion 31 formed using the coil wire 21, and no member such as the connecting fastener 104 described in the above-mentioned Patent Document 1 (Patent Publication No. 2584956) is attached, so that when the embolic coil 20 is placed at a predetermined position inside the body or a body cavity, for example, inside an affected area A (see Figure 6) such as an aneurysm generated in the middle of a blood vessel, the base end 25 side of the embolic coil 20 is unlikely to protrude into the flow path of a tubular organ V such as a blood vessel.
  • an affected area A see Figure 6
  • the embolization coil has a loosely wound portion and the first engagement portion has a coil gap portion that is wider than the axial gap between the coil wires in the loosely wound portion.
  • the pusher 40 is formed in a coil shape by winding the pusher wire 41, and the second engagement portion 49 has a pusher gap portion 51 formed by leaving a gap between the pusher wires 41, 41 in the axial direction.
  • the pusher gap portion 51 of the second engagement portion 49 provided at the tip portion 45 of the pusher 40 is also formed with a gap in the axial direction between the pusher wires 41, 41 (the gap is widened), so that the flexibility can be increased and the flexibility of the engagement portion between the first engagement portion 29 and the second engagement portion 49 can be further improved.
  • the above-mentioned effect can also be obtained when the pusher is provided with a loosely wound portion and the second engagement portion has a pusher gap portion that is formed wider than the axial gap between the pusher wires in the loosely wound portion.
  • the pusher wire 41 has lower rigidity than the coil wire 21.
  • the pusher 40 may become entangled with other embolic coils 20 that have already been placed. If the pusher 40 is forcibly pulled out in this state, the other embolic coils 20 that have already been placed may be pulled out.
  • the pusher wire 41 has a lower rigidity than the coil wire 21, so that by pulling the pusher 40 in the axial direction to move it away from the embolic coil 20, the second engagement portion 49 on the pusher 40 can be forcibly separated from the first engagement portion 29 on the embolic coil 20, and the embolic coil 20 can be detached from the pusher 40. Therefore, only the pusher 40 can be pulled out from within the affected area A, so that the already placed embolic coil 20 can be prevented from being pulled out of the affected area A, such as an aneurysm.
  • the embolization coil 20 can be maintained in a state wound with the coil wire 21 (has shape retention), and when the embolization coil 20 is placed at a predetermined position in the body or a body cavity, for example, inside an affected area A such as an aneurysm generated in the middle of a blood vessel, the base end 25 side of the embolization coil 20 can be made less likely to protrude into the flow path of a tubular organ V such as a blood vessel.
  • the coil wire 21 has a low rigidity, the coil wire 21 itself will be more likely to stretch, and there is a risk that the base end 25 of the embolization coil 20 will protrude into the flow path of a tubular organ V such as a blood vessel.
  • the embolization coil 20 is equipped with an extension restriction wire 35 that restricts extension.
  • the embolic coil 20 is equipped with an extension restriction wire 35 that restricts its extension.
  • the engagement portion where the first engagement portion 29 and the second engagement portion 49 are engaged has an enlarged diameter portion (here, the tip portion 42a of the diagonal extension portion 42 of the pusher 40 and the tip portion 22a of the diagonal extension portion 22 of the embolization coil 20) that is enlarged in diameter more than the other portions.
  • the engagement portion where the first engagement portion 29 and the second engagement portion 49 are engaged has an enlarged diameter portion that is larger in diameter than the remaining portions, and therefore the enlarged diameter portion can be positioned closer to the inner circumference of the medical tube 70.
  • the engagement between the first engagement portion 29 and the second engagement portion 49 within the medical tube 70 is less likely to come loose.
  • (Second embodiment of the embolic coil detachment device) 7 shows a second embodiment of an embolic coil detachment device according to the present invention. Note that parts that are substantially the same as those in the above embodiment are given the same reference numerals and their explanation will be omitted.
  • the structure of the embolic coil 20A and the pusher 40A differs from the previous embodiment.
  • the first engagement portion 29 provided on the base end 25 of the embolization coil 20A is shaped so as to bend in a direction away from the tip end 45 of the pusher 40A radially outward via the base end of the extending direction of the diagonal extending portion 22 (the first engagement portion 29 is shaped in a direction opening toward the densely wound portion 27).
  • the second engagement portion 49 provided on the tip portion 45 of the pusher 40A is shaped so as to bend in a direction away from the base end 25 of the embolization coil 20A in the radial outward direction via the base end of the extending direction of the diagonal extending portion 42 (the second engagement portion 49 is shaped in a direction opening toward the densely wound portion 47).
  • the wire diameter of the pusher wire 41 that forms the second engagement portion 49 of the pusher 40A is smaller than the wire diameter of the pusher wire 41 that forms the densely wound portion 47.
  • the first engagement portion 29 is flexibly deformed so as to be coaxial with the densely wound portion 27, and the second engagement portion 49 is flexibly deformed so as to be coaxial with the densely wound portion 47, so that both engagement portions 29, 49 are engaged with each other, and then the device is inserted into the medical tube 70.
  • the two engagement portions 29, 49 return to their original shape and move away from each other, reliably releasing the engagement between the two engagement portions 29, 49 and allowing the embolic coil 20A to be quickly detached from the pusher 40A.
  • the wire diameter of the pusher wire 41 forming the second engagement portion 49 of the pusher 40A is smaller than the wire diameter of the pusher wire 41 forming the densely wound portion 47, so the rigidity of the entire second engagement portion 49 is reduced, and the engagement force of the second engagement portion 49 with the first engagement portion 29 can be suppressed, making it easier to disengage the second engagement portion 49 from the first engagement portion 29.
  • FIG. 8 and 9 show a third embodiment of an embolic coil detachment device according to the present invention. Note that parts that are substantially the same as those in the above embodiment are given the same reference numerals and their explanation will be omitted.
  • the structure of the embolic coil 20B and the pusher 40B differs from the previous embodiment.
  • the first engagement portion 29 provided at the base end portion 25 of the embolization coil 20B has a loosely wound structure in which adjacent coil wires 21, 21 are wound with a gap between them in the axial direction.
  • the second engagement portion 49 provided at the tip portion 45 of the pusher 40B has a loosely wound structure in which adjacent pusher wires 41, 41 are wound with a gap between them in the axial direction.
  • the pusher wire 41 of the second engagement part 49 fits into the gap between the coil wires 21, 21 of the first engagement part 29 and engages with the wires 21, 21 located on both sides, while the coil wire 21 of the first engagement part 29 fits into the gap between the pusher wires 41, 41 of the second engagement part 49 and engages with the wires 41, 41 located on both sides, so that the two engagement parts 29, 49 engage with each other.
  • the wire of the second engaging portion 49 or the other member of the first engaging portion 29 enters the gap of one of the members of the first engaging portion 29 or the second engaging portion 49, and engages with and intertwines the wires on both sides, so that the two engaging portions 29, 49 engage with each other.
  • the movable wire 60 is pulled out of the internal space 23 of the embolic coil 20B and pulled so that it is not positioned in the lumen 43 at the tip 45 of the pusher 40B.
  • the pusher 40B is then pushed in, causing the first engagement portion 29 of the embolic coil 20B and the second engagement portion 49 of the pusher 40B to protrude from the opening at the tip 71 of the medical tube 70.
  • the first engaging portion 29 or the second engaging portion 49 is engaged with the wire of the other member of the second engaging portion 49 or the first engaging portion 29 in a manner such that the wires of the other member of the second engaging portion 49 or the first engaging portion 29 enter and become entangled in the gap between the first engaging portion 29 or the second engaging portion 49. Therefore, even if the movable wire 60 is pulled out while the engaging portions 29 and 49 are positioned within the medical tube 70, the engaged state of the engaging portions 29 and 49 can be stably maintained.
  • FIG. 10 to 12 show a fourth embodiment of an embolic coil detachment device according to the present invention. Note that parts that are substantially the same as those in the above embodiment are given the same reference numerals and their explanation will be omitted.
  • the embolic coil detachment device 10C of this fourth embodiment (hereinafter also simply referred to as "coil detachment device 10C") has an embolic coil 20C and a pusher 40, and does not have the movable wire 60 that is included in the embolic coil detachment devices of the first to third embodiments.
  • the pusher 40 has the same structure as that of the first embodiment.
  • the embolic coil 20C in this embodiment is basically configured similarly to the embolic coil 20 in the first embodiment, but the attachment structure of the extension restriction wire 35C is different. That is, the extension restriction wire 35C is connected to the base end 25 of the embolic coil 20C across the coil gap portion 31, and is also connected to the tip end (not shown) of the embolic coil 20C.
  • the extension restriction line 35C is positioned offset to one location in the radial direction of the embolic coil 20C.
  • the extension restriction line 35C is positioned offset to a location in the radial direction of the embolic coil 20C, away from the tip portion 42a of the diagonal extension portion 42 of the pusher 40 (biased toward the upper side of the paper in FIG. 10 in the radial direction of the embolic coil 20C).
  • extension restriction wire 35C passes through the coil gap portion 31 and is connected to the base end of the engagement end 33 of the first engagement portion 29 located at the base end 25, and is also connected to the tip of the tip portion (not shown) of the embolization coil 20C.
  • the extension restriction wire 35C is attached over the entire axial range from the base end to the tip of the embolization coil 20C.
  • the coil detachment device 10C having the above configuration is basically stored and transported in a substantially cylindrical case 80 as shown in FIG. 11.
  • the tip 81 of the case 80 can be connected to the base end 75 of a medical tube 70 such as a catheter.
  • the coil detachment device 10C is adapted to be housed in a medical tube 70 such as a catheter, for example, as follows. That is, as explained in paragraph 0081 etc., the medical tube 70 is guided and moved via a guidewire (not shown) using the well-known Seldinger technique or the like, until its tip reaches a predetermined position, and the guidewire is removed from the body. Then, as shown by the arrow in Figure 11, the tip 81 of the housing case 80 is inserted and connected to the base end 75 of the medical tube 70 (see the two-dot chain line in Figure 11).
  • the embolization coil 20C is accommodated in the medical tube 70 from the tip 81 of the case 80, as shown in FIG. 12.
  • the tip 81 of the case 80 is removed from the base end 75 of the medical tube 70.
  • the above-mentioned method of storing an embolic coil inside a medical tube can also be used in the embolic coil detachment device of the first to third embodiments.
  • the embolic coil 20C is moved within the medical tube 70 while being pushed by the pusher 40.
  • the embolic coil 20C is then pushed out from the opening at the tip 71 of the medical tube 70, and the first engagement portion 29 of the embolic coil 20C and the second engagement portion 49 of the pusher 40 are caused to protrude from the opening at the tip 71 of the medical tube 70.
  • the coil gap portion 31 of the first engagement portion 29 provided at the base end portion 25 of the embolic coil 20C is formed with a gap between the coil wires 21, 21 in the axial direction, thereby increasing the flexibility of the coil gap portion 31 of the embolic coil 20C.
  • the second engagement portion 49 of the pusher 40 is configured to radially engage with the highly flexible coil gap portion 31, the flexibility of the engagement portion between the first engagement portion 29 and the second engagement portion 49 can be improved. As a result, the coil detachment device 10C can be easily inserted into bent tubular organs, body cavities, etc.
  • this coil detachment device 10C has an embolic coil 20C and a pusher 40, but does not have a movable wire 60, there is no need to manipulate the movable wire 60, such as pulling it out of the internal space 23 of the embolic coil 20C or pulling it so that it is not positioned in the lumen at the tip 45 of the pusher 40.
  • the ease of placement of the embolic coil 20C in the desired affected area can be improved compared to the embolic coil detachment devices of the first to third embodiments.
  • the manufacturing costs of the coil detachment device 10C can be reduced accordingly, and the structure of the embolic coil detachment device can be simplified.
  • the first engagement portion 29 of the embolic coil 20C and the second engagement portion 49 of the pusher 40 are protruded from the opening at the tip 71 of the medical tube 70.
  • the extension restriction wire 35C is connected to the base end 25 of the embolic coil 20C across the coil gap portion 31, and is also connected to the tip end (not shown) of the embolic coil 20C.
  • the axial range of the embolic coil 20C from the base end to the tip is less likely to stretch.
  • it becomes easier to maintain the adjacent coil wires 21, 21 that make up the engagement end 33 of the first engagement portion 29 of the embolic coil 20C in a close contact state it becomes easier to prevent gaps in the pitch).
  • the engagement end 33 of the first engagement portion 29 of the embolic coil 20C tilts radially outward away from the engagement end 53 of the second engagement portion 49 of the pusher 40, sufficiently preventing the engagement between the first engagement portion 29 and the second engagement portion 49 from being released, and the position of the embolic coil 20C relative to the affected area can be reliably corrected.
  • the extension restriction line 35C arranged in a tensioned state in the gap portion 31 is stretched.
  • the reaction force of the extension restriction line 35C acts on the engagement end 53 of the pusher 40, applying a force to the engagement end 53 to move radially outward. Therefore, when both engagement portions 29, 49 are protruded from the opening of the tip end 71 of the medical tube 70, the reaction force of the extension restriction line 35C makes it easier for the engagement portions 29, 49 to be released from their engaged state, improving the ease of placement of the embolization coil 20C in the desired affected area.
  • the range from the base end to the tip in the axial direction is less likely to stretch, making it easier to maintain the performance required of the embolization coil 20C (e.g., the performance of the embolization coil forming a mass within the affected area to facilitate occlusion of the affected area, etc.), and the affected area can be sufficiently occluded (embolized).
  • the extension restriction line 35C in this embodiment is positioned in the radial direction of the embolization coil 20C, away from the tip portion 42a of the diagonal extension portion 42 of the pusher 40.
  • the extension restriction line 35C is less likely to interfere with the engagement end 53 of the second engagement portion 49 of the pusher 40, and the engagement operation of both engagement portions 29, 49 can be performed smoothly.
  • Embolic coil detachment device (coil detachment device) 20, 20A, 20B, 20C Embolization coil 21 Coil wire 25 Base end 27 Densely wound portion 29 First engagement portion 31 Coil gap portion 35 Extension restriction line 40, 40A, 40B Pusher 41 Pusher wire 43 Lumen 45 Tip 47 Densely wound portion 49 Second engagement portion 51 Pusher gap portion 60 Movable wire 70 Medical tube

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Abstract

L'invention concerne un dispositif de détachement de spirale d'embolisation qui peut être facilement inséré dans un organe tubulaire incurvé, un tissu corporel humain et similaire. Ce dispositif de détachement de spirale d'embolisation (10) est pourvu d'une spirale d'embolisation (20), d'un poussoir (40) et d'un fil mobile (60), dans lequel une première partie de mise en prise (29) est disposée au niveau d'une partie d'extrémité proximale (25) de la spirale d'embolisation (20), la première partie de mise en prise (29) présente une partie d'espace de spirale (31), une seconde partie de mise en prise (49) apte à venir en prise avec la partie d'espace de spirale (31) à partir de la direction de diamètre de la spirale d'embolisation (20) est disposée au niveau de la partie d'extrémité distale (45) du poussoir (40), le fil mobile (60) maintient l'état en prise des deux parties de mise en prise (29, 49) lorsque le fil mobile (60) est inséré dans la spirale d'embolisation (20) et une cavité interne du poussoir (40), et la mise en prise entre les deux parties de mise en prise (29, 49) peut être libérée lorsque le fil mobile (60) est retiré de l'intérieur de la spirale d'embolisation (20).
PCT/JP2023/045530 2022-12-22 2023-12-19 Dispositif de détachement de spirale d'embolisation WO2024135691A1 (fr)

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JP2022-205933 2022-12-22
JP2022205933 2022-12-22

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH08238320A (ja) * 1994-12-22 1996-09-17 Target Therapeutics Inc 拡張可能な連結／脱連結メカニズムを備えたインプラント送達アセンブリ
JPH09108229A (ja) * 1995-06-30 1997-04-28 Target Therapeutics Inc 伸張抵抗性血管閉塞コイル
JP2008525113A (ja) * 2004-12-22 2008-07-17 ボストン サイエンティフィック リミテッド 回動可能なカップリングを有する脈管閉塞デバイス
US20110046610A1 (en) * 2009-08-19 2011-02-24 Cook Incorporated Over-the-wire detachment mechanism
JP2022516573A (ja) * 2019-06-05 2022-02-28 エンドシェープ，アイエヌシー． 閉塞および送達を改善するためのシステム、デバイス、および方法

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH08238320A (ja) * 1994-12-22 1996-09-17 Target Therapeutics Inc 拡張可能な連結／脱連結メカニズムを備えたインプラント送達アセンブリ
JPH09108229A (ja) * 1995-06-30 1997-04-28 Target Therapeutics Inc 伸張抵抗性血管閉塞コイル
JP2008525113A (ja) * 2004-12-22 2008-07-17 ボストン サイエンティフィック リミテッド 回動可能なカップリングを有する脈管閉塞デバイス
US20110046610A1 (en) * 2009-08-19 2011-02-24 Cook Incorporated Over-the-wire detachment mechanism
JP2022516573A (ja) * 2019-06-05 2022-02-28 エンドシェープ，アイエヌシー． 閉塞および送達を改善するためのシステム、デバイス、および方法

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